510(k) · Cleared
ClearediNtuition-Structural Heart Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terarecon,Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 12, 2019 as substantially equivalent to K153736 (Pie Medical Imaging BV, 2016) and 1 other predicate after a 28-day review. Its family tree reaches back 8 generations to 1991. 2 later devices descend from it.
- Decided
- Jul 12, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 66 ancestors in all, the oldest K871859 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 6 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 5 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 4 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 3 generations backK041807 Lung Car 1.1Medicsight · 2004
- 2 generations backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- 1 generation backK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
- This deviceK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- Descendant · cites it directly · 1 of its ownK250337 AiORTA - PlanViTAA Medical Solutions, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK254207 AiORTA - Plan v2.0ViTAA Medical Solutions, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −6 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −5 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −3 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −2 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| −1 | K121916 | Intuition | Terarecon,Inc. | 2013 | 1 |
| 0 (this device) | K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019 | — |
| +1 | K250337 | AiORTA - Plan | ViTAA Medical Solutions, Inc. | 2025 | — |
| +2 | K254207 | AiORTA - Plan v2.0 | ViTAA Medical Solutions, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153736 | 3mensio WorkstationSummary page 4…de: LLZ Classification Panel: Radiology Device Classification: Class II Predicate Devices:: - 3mensio Workstation (K153736) (Primary predicate device) - iNtuition (K121916) (Secondary predicate device) Indications for Use: iNtuition-Structur… | 2016 |
| * | K121916 | IntuitionSummary page 4…Radiology Device Classification: Class II Predicate Devices:: - 3mensio Workstation (K153736) (Primary predicate device) - iNtuition (K121916) (Secondary predicate device) Indications for Use: iNtuition-Structural Heart Module is a software solution that is intended… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250337 | AiORTA - Plan | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 13 of the 66 ancestors have a recall of any class.
- Of its descendants, K250337 (ViTAA Medical Solutions, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K153736.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and Clinical Specialists with the visualization and measurements of structures of the heart and vessels. iNtuition-Structural Heart Module enables the user to: * Visualize and measure (diameters, lengths, angles, areas and volumes) structures of the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and…
Read the full statement (132 words)
iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and Clinical Specialists with the visualization and measurements of structures of the heart and vessels.
iNtuition-Structural Heart Module enables the user to:
* Visualize and measure (diameters, lengths, angles, areas and volumes) structures of the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and surgery, and for post-operative evaluation.
* Quantify calcium (volume, density)
iNtuition-Structural Heart Module has the following tools and features that facilitate:
» Automatic and manual centerline detection.
» Segmentation of cardiovascular structures.
» Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions of vessels and structures.
* Calcium quantification and scoring.
Various visualization techniques: 2D/3D/4D visualization, MPR, Curved MPR, Stretched MPR, MIP, MinIP, Raysum and MAR.
* Capture and Report.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191585: iNtuition-Structural Heart Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191585
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026